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Sensitivity of Short and Long Allele Carriers of the 5-HTTLPR to Environmental Threat Post Hydrocortisone Administration (5-HTTLPR)

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ClinicalTrials.gov Identifier: NCT01710202
Recruitment Status : Completed
First Posted : October 19, 2012
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
University of Texas at Austin

Brief Summary:
The current study will test the causal relationship between elevated levels of cortisol and the serotonin transporter gene (5-HTTLPR) as these factors influence sensitivity to environmental threat. The investigators predict that carriers of the short allele of the serotonin transporter gene who have elevated cortisol levels will be most sensitive to threatening environments, whereas carriers of the long allele who do not have elevated cortisol (placebo subjects) will be least sensitive.

Condition or disease Intervention/treatment
Major Depressive Disorder Anxiety Disorders Drug: Hydrocortisone

Detailed Description:
Depression vulnerability has been linked to certain variants of the serotonin transporter gene. Research indicates that a polymorphism of the serotonin transporter (5-HTTLPR) gene appears to moderate the association between life stress and depression onset. Life stress robustly predicts depression onset for individuals with two short 5-HTTLPR alleles. Individuals homozygous for the short 5-HTTLPR allele thus appear to be more sensitive to the effect of life stress, which in turn contributes to depression onset. A recent study showed that short allele carriers presented with a threat (social or other threats) who also had high levels of testosterone had elevated cortisol after exposure to the threat. There is neurobiological evidence that short allele status, elevated testosterone levels, and elevated cortisol levels are all linked to amygdala hyper-reactivity to the same classes of environmental threats. Thus, this study will test, for the first time, a potential interaction between 5-HTTLPR status and experimentally manipulated cortisol levels as risk factors for downstream mood and/or anxiety disorders by examining potential dysregulated stress responses among short allele carriers who have elevated cortisol levels.

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case Control
Official Title: Sensitivity of Short and Long Allele Carriers of the 5-HTTLPR to Environmental Threat Post Hydrocortisone Administration
Study Start Date : October 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : November 2014


Group/Cohort Intervention/treatment
Placebo
Control group who will not receive hydrocortisone. Will act as a comparison group to the hydrocortisone group.
Experimental: Hydrocortisone
Group will receive 20mg oral hydrocortisone
Drug: Hydrocortisone
Each subject in this group will receive one 20mg hydrocortisone capsule to be taken by mouth.
Other Names:
  • Cortef
  • Cortisol
  • Hydrocortone




Primary Outcome Measures :
  1. Change in testosterone concentration [ Time Frame: 2 hours post hydrocortisone administration ]
    Subjects will be administered hydrocortisone or placebo. One hour after administration, they will be exposed to an environmental threat manipulation. 20 minutes after this manipulation, saliva will be collected, and testosterone concentrations will be assessed and compared to pre-manipulation concentrations


Biospecimen Retention:   Samples With DNA
Saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
University of Texas at Austin students
Criteria

Inclusion Criteria:

  • None

Exclusion Criteria:

  • Are you under the age of 18 years old?
  • Have you ever had an allergic reaction to hydrocortisone?
  • Do you have diabetes or high blood pressure?
  • Do you have any thyroid, liver, heart, lung, or kidney problems?
  • Do you have herpes, HIV or any sexual transmitted disease?
  • Are you currently pregnant or think you might be pregnant? Have you taken RU486, Plan B or "Morning After Pill" within the last 2 weeks? - Are you currently breastfeeding?
  • Have you been sick within the last week? Do you have any fungal infections?
  • Have you been exposed to measles or chicken pox in the last week?
  • Have you ever had a seizure?
  • Do you have any disease of bony tissue, such as osteoporosis?
  • Do you have any autoimmune diseases, such as myasthenia gravis?
  • Do you have multiple sclerosis?
  • Do you have any condition that compromises you immune system function or causes you to be more likely to get sick?
  • Have you had any recent surgeries?
  • Do you have and gastrointestinal problems, such as ulcers, diverticulitis, colitis, hepatitis, or Crohn disease?
  • Are you taking any of the following medications: nevirapine, telbivudine, sipuleucel-T (IV), natalizumab (IV)?
  • Have you received any vaccinations within the last week?
  • With the exception of vitamins, have you taken any medications in the last 3 days, including all over-the counter medications and/or supplements (e,g. Tylenol, ibuprofen, St. John's Wort, cold remedies)?
  • Do you currently have or have you had in the past of any kind of cancer?
  • Do you have any significant medical or psychiatric illnesses not listed above?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710202


Locations
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United States, Texas
University of Texas at Austin Department of Psychology
Austin, Texas, United States, 78712
University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Robert A Josephs, Ph.D. University of Texas at Austin

Publications:
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Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01710202     History of Changes
Other Study ID Numbers: 2011-12-0017
First Posted: October 19, 2012    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: August 2013
Keywords provided by University of Texas at Austin:
Hydrocortisone
Cortisol
Testosterone
Stress
Serotonin
5-HTTLPR
Amygdala
Depression
Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Disease
Depressive Disorder
Depressive Disorder, Major
Anxiety Disorders
Pathologic Processes
Mood Disorders
Mental Disorders
Anti-Inflammatory Agents